You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 16, 2025

Details for New Drug Application (NDA): 213581

✉ Email this page to a colleague

« Back to Dashboard

NDA 213581 describes ATROPINE SULFATE, which is a drug marketed by Us Army, Amneal, Apotex, Bausch And Lomb Inc, Mankind Pharma, Rising, Somerset, Somerset Theraps Llc, Accord Hlthcare, Am Regent, Hikma, Hospira, Intl Medication Sys, Medefil Inc, and Fresenius Kabi Usa, and is included in twenty-one NDAs. It is available from twenty-four suppliers. Additional details are available on the ATROPINE SULFATE profile page.

The generic ingredient in ATROPINE SULFATE is atropine sulfate. There are twenty-three drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the atropine sulfate profile page.

Summary for 213581

Tradename:	ATROPINE SULFATE
Applicant:	Bausch And Lomb Inc
Ingredient:	atropine sulfate
Patents:	0

Pharmacology for NDA: 213581

Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Suppliers and Packaging for NDA: 213581

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ATROPINE SULFATE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	213581	NDA	Bausch & Lomb Incorporated	24208-965	24208-965-01	10 VIAL in 1 CARTON (24208-965-01) / .4 mL in 1 VIAL
ATROPINE SULFATE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	213581	NDA	Bausch & Lomb Americas Inc.	82260-001	82260-001-01	10 VIAL in 1 CARTON (82260-001-01) / .4 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	1%
Approval Date:	Mar 15, 2022	TE:		RLD:	Yes

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.